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Trial record 31 of 8764 for:    Eye AND Eye Diseases

Closed Eye Neutrophils in Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03332342
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Allergan Sales, LLC
Information provided by (Responsible Party):
Kelly Nichols, University of Alabama at Birmingham

Brief Summary:
The purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. This study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. While a diagnostic technique, the eye wash may also have a therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this project.

Condition or disease Intervention/treatment Phase
Dry Eye Ocular Inflammation Other: Eye wash Not Applicable

Detailed Description:
Every night during sleep, there is an influx of white blood cells on to the surface of the eye. These cells likely perform a protective function, but it is also possible that their dysregulation could lead to disease. Using a larger cohort, our investigation hopes to better understand the function of these cells and their potential to be linked to dry eye disease. Further, the way in which these cells are collected, using an at-home self-collection of tears using an eye wash method with sterile saline solution, immediately upon awakening, could potentially provide relief to dry eye sufferers if performed on a daily basis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of Closed Eye Neutrophils on Dry Eye Disease Pathogenesis: Investigation on Repeatability and Effectiveness of an Eye Wash at Awakening for Diagnosis and Therapy
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Daily rinse of ocular surface
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily.
Other: Eye wash
Research subjects will perform a wash of their ocular surface with phosphate buffered saline

Active Comparator: Weekly rinse of ocular surface
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly.
Other: Eye wash
Research subjects will perform a wash of their ocular surface with phosphate buffered saline

Experimental: Occasional rinse of ocular surface
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions
Other: Eye wash
Research subjects will perform a wash of their ocular surface with phosphate buffered saline




Primary Outcome Measures :
  1. Comfort assessment using the dry eye questionnaire [ Time Frame: Baseline to 4 weeks ]
    Mean change from baseline in comfort following daily ocular surface washes

  2. Comfort assessment using the ocular surface disease index [ Time Frame: Baseline to 4 weeks ]
    Mean change from baseline in comfort following daily ocular surface washes


Secondary Outcome Measures :
  1. Repeatability of diagnostic in measuring leukocyte count [ Time Frame: Baseline to 4 weeks ]
    Repeatability of the eye wash in terms of leukocyte count, as measured by flow cytometry

  2. Repeatability of diagnostic in measuring leukocyte phenotype [ Time Frame: Baseline to 4 weeks ]
    Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • able to understand and sign an informed consent and HIPAA privacy document
  • greater than 18 years of age at time of informed consent
  • able and willing to follow protocol instructions, including performing at-home washes of the ocular surface and subsequent delivery of those samples to campus on a regular basis
  • must be willing to have blood drawn

Exclusion Criteria:

  • contact lens wear within past three months
  • current consumption of cigarettes or tobacco, including e-cigarettes
  • participation in any investigational drug studies within 30 days of informed consent
  • pregnancy, by self-report
  • active ocular infection or inflammation
  • any refractive surgery within the past year
  • any present Accutane (Isotretinoin) use
  • any medication usage that, in the investigator's opinion, could be expected to interfere with the study, such as current use of topical steroids, Restasis, or Xiidra
  • have any uncontrolled systemic disease, that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332342


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Allergan Sales, LLC
Investigators
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Principal Investigator: Kelly K Nichols, OD MPH PhD UAB School of Optometry

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Responsible Party: Kelly Nichols, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03332342     History of Changes
Other Study ID Numbers: 000517538
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Nichols, University of Alabama at Birmingham:
dry eye disease
tears
inflammation
ocular surface

Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Inflammation
Keratoconjunctivitis Sicca
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Keratitis